(142 days)
TECHFIT Digitally Integrated Surgical Reconstruction Platform (DISRP) System is intended for use as a software system and image segmentation system for the transfer of imaging information from a medical scanner such as a CT based system. The input data file is processed by the DISRP System and the result is an output data file that may then be provided as digital models or used as input to a rapid prototyping portion of the system that produces physical outputs including surgical guides and splints for use in maxillofacial surgery. The DISRP System is also intended as a preoperative software tool for simulating / evaluating surgical treatment options.
The DISRP system is compatible with the TECHFIT Patient- Specific Maxillofacial System and the TECHFIT Diagnostic Models and should be used in conjunction with expert clinical judgment.
The TECHFIT DISRP SYSTEM is composed by Orthognathic Surgical Guides and the Digitally Integrated Surgical Reconstruction Platform (DISRP).
Digitally Integrated Surgical Reconstruction Platform (DISRP)
The Digitally Integrated Surgical Reconstruction Platform (DISRP) is a web-based collaboration software for digital surgery case flow management and Orthognathic surgery planning that reflects the production process and allows for the interaction of multiple users: surgeons, sales representatives, and the TECHFIT case planning staff (case planning assistant, case planners, and operations director), using multiple devices. It allows easy collaboration in the planning process. Being web-based allows immediate and convenient sharing without the installation or maintenance of the application at the user's end.
Orthognathic Surgical Guides
Orthognathic Surgical Guides are Patient-Specific single use devices that are designed to assist the surgeon in transferring the pre-surgical plan to the operation room. Surgical Guides are intended for Orthognathic surgeries in adults and have drilling holes and slots for making drillings and osteotomies, as well as they guide the correct positioning of bones and implants.
Orthognathic Surgical Guided into two types: Resin Orthognathic Surgical Guides and Machined Orthognathic Surgical Guides.
- Resin Orthognathic Surgical Guides
Resin Orthognathic Surgical Guides include surgical guides and splints.
Surgical Guides consist of the Le Fort and Genioplasty surgical quides, which are composed of a body that is manufactured by TECHFIT Digital Surgery and produced by rapid prototyping with the Form 3B printer and Biomed Clear Resin from Formlabs, Somerville, United States.
In surgery Surgical Guides must be used with Metal Sleeves. There are three types of metal sleeves: slot metal sleeve, drill metal sleeve and screw metal sleeve. The slot, drill and screw metal sleeves are manually fitted by the healthcare professional during surgery into the slots, drilling holes and fixation holes of the surgical guide. The metal sleeves are produced from commercially pure titanium grade 4 through machining and are manufactured equivalent to the TECHFIT Patient-Specific Maxillofacial System (K203282) and AFFINITY Proximal Tibia System (K220199). In addition, the Metal Sleeves are single-use and patient-specific accessories.
The Splints are optional quides used in orthognathic surgery to quide to the correct teeth positioning and to validate the patient's final occlusion. The Splints are manufactured by TECHFIT Digital Surgery and produced by rapid prototyping using the Form 3B printer and Biomed Clear Resin from Formlabs, Somerville, United States.
- Machined Orthognathic Surgical Guides
Machined Orthognathic Surgical Guides consist of the Le Fort and Genioplasty surgical guides that are manufactured from the same material (commercially pure titanium grade 4) and in a manufacturing process equivalent to the TECHFIT Patient-Specific Maxillofacial System (K203282) and AFFINITY Proximal Tibia System (K220199) manufactured through machining.
Machined Orthognathic Surgical Guides and Metal Sleeves are manufactured with the same material and same manufacturing process.
The provided text describes the TECHFIT DISRP® System, including its indications for use, comparison to predicate devices, and performance data from non-clinical testing. However, it does not contain details about a study evaluating the performance of an AI/algorithm component against specific acceptance criteria related to its accuracy or diagnostic capability, nor does it mention any human-in-the-loop studies (MRMC) or standalone algorithm performance studies.
The "Performance Data" section primarily addresses:
- Safety testing: Validating sterilization methods.
- Performance testing: Dimensional validation (comparing physical guides to digital designs), mechanical testing (withstanding forces), and compatibility testing with other systems.
- Software testing: Verification and validation of the DISRP software itself as per IEC 62304.
- Biocompatibility testing: For the materials used in the surgical guides and metal sleeves.
Therefore, based solely on the provided text, I cannot fill out the requested table and details regarding acceptance criteria for an AI/algorithm and a study proving its performance in the context of diagnostic accuracy or reader improvement. The device described appears to be a software system for planning and producing physical surgical guides and splints, not an AI for image interpretation or diagnosis.
If the "DISRP System" inherently contains an AI component for, say, auto-segmentation or surgical plan optimization that would require diagnostic-like performance evaluation, that information is not present in the provided excerpt.
Assuming the request refers to the acceptance criteria for the overall system's performance as described, rather than an AI's diagnostic accuracy:
Here's how I can address the request based on the available information, while highlighting what's not present:
Response based on the provided document:
The provided document describes the TECHFIT DISRP® System, which is a software system and image segmentation system used for surgical planning and the production of physical surgical guides and splints. It is not an AI diagnostic device in the traditional sense that generates clinical interpretations or provides diagnostic classifications. Therefore, the acceptance criteria and study details commonly associated with AI performance validation (like sensitivity, specificity, MRMC studies, ground truth establishment for diagnostic tasks) are not applicable to the data presented in this FDA 510(k) summary.
The performance data presented focuses on the physical and software validation of the device, ensuring it meets its intended use of accurately transferring imaging information to produce dimensionally correct and mechanically sound surgical guides and splints, and that the software functions as intended.
Here's a breakdown based on the provided text, addressing the points where information is available or noting its absence:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (for the system's function/physical output) | Reported Device Performance (from "Performance Data") |
|---|---|
| Dimensional Validation: Orthognathic surgical guides maintain proportions and dimensions of original digital design after manufacturing and sterilization. | Conclusion: "DISRP and Orthognathic surgical guides maintain the proportions and dimensions of the original digital design after manufacturing and sterilization." (Test Method: "Scanning of orthognathic surgical guides and then comparing them versus the original files, before and after sterilization.") |
| Mechanical Testing: Orthognathic surgical guides can withstand maximum bite force, drilling force, and general surgical handling force. | Conclusion: "Orthognathic Surgical Guides withstand bit force and the force applied by the surgeon during handling." (Test Method: "Bending and compressive strength, after sterilization. Evaluating if the orthognathic surgical guides can withstand the maximum bite force, force required for drilling and handle force required for a general surgery.") |
| Software Validation: Software meets IEC 62304 standards for verification and validation. | Conclusion: "DISRP software was verified and validated as per IEC 62304." (Test Method: "Software verification and validation activities") |
| Sterilization Efficacy: Achieves a Sterility Assurance Level (SAL) of 10^-6 for steam sterilization. | Conclusion: "The results of the steam sterilization validation show that TECHFIT Orthognathic Surgical Guides sterilized to a SAL of 10^-6 using the recommended steam sterilization instructions." (Test Method: AAMI/ISO 17665-1:2006/(R)2013 and ANSI/AAMI/ISO 14937:2009/(R)2013) |
| Biocompatibility (Resin Guides): No cytotoxic, sensitizing, irritant, acute systemic toxicity, pyrogenic, or genotoxic properties. Non-toxic chemical characterization. | Conclusion: All biocompatibility tests (Cytotoxicity, Sensitization, Irritation, Acute systemic toxicity, Pyrogenicity, Chemical Characterization) were concluded with "No..." or "Non-toxic" findings in compliance with respective ISO standards (ISO 10993-5, 10993-10, 10993-11, 10993-18, 10993-17). |
| Biocompatibility (Machined Guides/Sleeves): No cytotoxic, sensitizing, irritant, acute systemic toxicity, pyrogenic, or genotoxic properties. Non-toxic chemical characterization. | Conclusion: All biocompatibility tests (Cytotoxicity, Sensitization, Irritation, Acute systemic toxicity, Pyrogenicity, Genotoxicity, Chemical Characterization) were concluded with "No..." or "Non-toxic" findings in compliance with respective ISO standards (ISO 10993-5, 10993-10, 10993-11, 10993-3, 10993-18, 10993-17). |
| Compatibility: Compatible with the Maxillofacial System and Metal Sleeves. | Conclusion: "Orthognathic Surgical Guides are compatible with the Maxillofacial System and Metal Sleeves." (Test Method: "Verifying compatibility between the Maxillofacial System and orthognathic surgical guides") |
Details Regarding Studies (as pertains to this type of device):
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Sample sizes used for the test set and the data provenance:
- The document mentions "Scanning of orthognathic surgical guides" and "Bending and compressive strength" tests but does not specify the sample size (number of guides or tests performed) for these non-clinical performance validations.
- The data provenance is not explicitly stated in terms of country of origin for test materials or whether tests were retrospective or prospective, beyond general statements about testing performed for FDA submission. These are typical engineering validation tests, not clinical trials.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable for this type of device validation. The "ground truth" here is based on engineering specifications, material properties, and adherence to digital designs, not expert clinical interpretation of images.
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Adjudication method for the test set:
- Not applicable. This is not a human-reader study requiring adjudication for diagnostic accuracy.
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If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- No. An MRMC study was not described. This device is for surgical planning and guide production, not for AI-assisted diagnostic interpretation by human readers.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- The "Software testing" indicates that the "DISRP software was verified and validated as per IEC 62304," which is a standard for medical device software lifecycle processes. This constitutes a standalone validation of the software's functionality and safety, but not a performance evaluation in terms of diagnostic accuracy or interpretation, as it is not a diagnostic AI.
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The type of ground truth used:
- The ground truth for the dimensional validation is the original digital design files of the surgical guides.
- For mechanical testing, the ground truth is engineering specifications for load-bearing capacity (e.g., maximum bite force, drilling force).
- For software validation, the ground truth is the specified software requirements and the IEC 62304 standard.
- For biocompatibility, the ground truth is the ISO 10993 series of standards for biological evaluation of medical devices.
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The sample size for the training set:
- Not applicable. This document does not describe a machine learning algorithm that requires a training set. The "DISRP System" is described as a "software system and image segmentation system for the transfer of imaging information," implying rule-based or conventional image processing for segmentation rather than a data-driven AI model that learns from large training datasets.
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How the ground truth for the training set was established:
- Not applicable as no training set for an AI model is described.
§ 872.4120 Bone cutting instrument and accessories.
(a)
Identification. A bone cutting instrument and accessories is a metal device intended for use in reconstructive oral surgery to drill or cut into the upper or lower jaw and may be used to prepare bone to insert a wire, pin, or screw. The device includes the manual bone drill and wire driver, powered bone drill, rotary bone cutting handpiece, and AC-powered bone saw.(b)
Classification. Class II.